Aidant TLC: in-person and online support for informal caregivers
Évaluation de l'efficacité du Programme " Aidant TLC " en présentiel et à Distance Sur le Bien-être Des Aidants Naturels
This project tests whether the Aidant TLC program, delivered online or in person, helps informal caregivers reduce depressive symptoms and feel more confident in their caregiving role.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innovation Alzheimer Academic / other |
| Locations | 2 sites (Biot and 1 other locations) |
| Trial ID | NCT07558356 on ClinicalTrials.gov |
What this trial studies
This randomized trial will enroll 75 informal caregivers and randomly assign them to receive the Aidant TLC psychosocial and educational program either remotely, in person, or to a no-intervention waitlist control. The intervention consists of weekly group sessions focused on emotional regulation, interpersonal skills, and stress management, with questionnaires administered before and after the program. Primary outcomes are changes in depressive symptoms and caregiving self-efficacy, with secondary outcomes including caregiver burden, anxiety, perceived benefits of caregiving, empathy, apathy, and adherence comparisons between delivery formats. The program was developed and tested in the United States but has not previously been evaluated in France.
Who should consider this trial
Good fit: Informal caregivers of adults needing help with daily activities who provide at least 4 hours of care per week, speak French, and either have internet access (for remote delivery) or can travel to Nice or Biot (for in-person sessions).
Not a fit: People unable to provide informed consent, those without internet access who cannot travel for in-person sessions, or caregivers who do not need psychosocial support are unlikely to participate or gain benefit from this program.
Why it matters
Potential benefit: If successful, the program could reduce depressive symptoms and increase caregiving confidence and coping skills, improving day-to-day well-being for caregivers.
How similar studies have performed: Related psychoeducational caregiver programs, including versions of Aidant TLC tested in the United States, have shown promising improvements in mood and self-efficacy, but this specific program has not yet been replicated in France.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being an informal caregiver of an adult requiring assistance with activities of daily living * Providing at least 4 hours of care per week (broadly defined, including direct care as well as help with tasks such as medication management and bill payment) * French-speaking * Ability to travel (for the in-person intervention) to Nice or Biot (France) * Access to the internet at home or in an easily accessible location (for the remote intervention). Exclusion Criteria: * Inability to provide informed consent.
Where this trial is running
Biot and 1 other locations
- Créapolis — Biot, France (Recruiting)
- Institut Claude Pompidou — Nice, France (Recruiting)
Study contacts
- Principal investigator: Valeria Manera, PhD — Université Cote d'Azur
- Study coordinator: Philippe Robert, Professor
- Email: phil.robert15@orange.fr
- Phone: +33 4 92034770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.